EORTC conducting phase III trial for patients with gastro-esophageal junction and stomach cancer

Worldwide, gastric cancer is a leading cause of cancer-related deaths. The current five-year survival rate for gastric cancer in developed countries is only about 20-30%. More alarming, however, is that even though the incidence of gastric adenocarcinoma has been decreasing, the incidence of adenocarcinoma of the esophagus and of the gastro-esophageal junction has been increasing over the past forty years.

The only treatment offering a potential cure for gastric and esophagogastric junction adenocarcinoma is surgery, but the majority of patients present with locally advanced or metastatic disease, and the prognosis for them is poor. It is thought that by combining chemotherapy and radiotherapy, we might provide improved treatment for these patients.

The newly opened phase II/III EORTC 22114 – 40111 TOP GEAR (Trial Of Preoperative therapy for Gastric and Esophagogastric junction AdenocaRcinoma) will test whether adding chemoradiotherapy to chemotherapy is superior to chemotherapy alone in the preoperative treatment of resectable gastric cancer.

The phase II part of this randomized phase II/III trial plans to accrue 120 patients and will be conducted in 35 sites in nine countries, Belgium, France, Germany, Israel, Czech Republic, Slovenia, Spain, Turkey, and Italy, and is designed to demonstrate the efficacy of chemoradiotherapy and thereby justify the phase III trial which will determine if chemoradiotherapy is superior to chemotherapy in these patients. The phase III part of this trial will recruit an additional 632 patients to include a total of 752 patients and will be conducted in 35 sites in 9 countries.

Dr. Karin Haustermans of the Universitair Ziekenhuis Leuven – Campus Gasthuisberg, and Coordinator of this study says, “Thanks to a joint effort of the most important clinical trial groups throughout the world, it is possible to run this practice changing Phase II/III trial.”

The intergroup TOP GEAR is led by the Australasian Gastro-intestinal Trials Group in collaboration with the EORTC Radiation Oncology and Gastrointestinal Tract Cancer Groups, the Belgian Group of Digestive Oncology, the Trans-Tasman Radiation Oncology Group, the National Cancer Institute of Canada Clinical Trials Group, and the National Health and Medical Research Council Clinical Trials Centre. It is supported by the EORTC Academic Fund.

For more information concerning EORTC 22114 – 40111 TOP GEAR please contact: www.eortc.org/contact

John Bean, PhD
EORTC, Medical Science Writer

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